Treatment of Chronic Low Back and Lower Extremity Pain

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT00681447
First received: March 14, 2008
Last updated: June 20, 2013
Last verified: June 2013
  Purpose
  1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
  2. To evaluate and compare the adverse event profile in all patients.

Condition Intervention
Low Back Pain
Procedure: Lumbar Interlaminar Epidural
Procedure: Lumbar Interlaminar Epidural injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain

Resource links provided by NLM:


Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:
  • To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ] [ Designated as safety issue: No ]
  • To evaluate and compare the adverse event profile in all patients. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group I
Lumbar interlaminar epidural injection with local anesthetic only
Procedure: Lumbar Interlaminar Epidural
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone

Procedure: Lumbar Interlaminar Epidural injection
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone

Group II
Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone
Procedure: Lumbar Interlaminar Epidural
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone

Procedure: Lumbar Interlaminar Epidural injection
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of at least 18 years of age
  • Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation
  • Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
  • Subjects have not had recent surgical procedures within the last 3 months.

Exclusion Criteria:

  • Cauda Equina symptoms and/or compressive radiculopathy
  • Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
  • Uncontrolled major depression or uncontrolled psychiatric disorders
  • Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
  • Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
  • Women who are pregnant or lactating
  • Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
  • Patients with multiple complaints involving concomitant hip osteoarthritis, due to the overlap of pain complaints
  • Inability to achieve appropriate positioning and inability to understand informed consent and protocol
  • History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
  • Previous surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681447

Locations
United States, Kentucky
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42001
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center, Paducah
  More Information

No publications provided by Pain Management Center of Paducah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00681447     History of Changes
Other Study ID Numbers: protocol 15
Study First Received: March 14, 2008
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:
lumbar disc herniation
discogenic pain
lumbar interlaminar epidural
injections

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014